Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section

NCT02549105 | Unknown Phase 4 DMC

• 1 other identifier: Ain Shams MH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.

Conditions

Post Operative Pain

Keywords

EMLA CREAM; LIDOCAINE INFILTERATION; PAIN RELIEF

Outcome Measures

Primary Outcomes (1)

• TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS

  6 H

Secondary Outcomes (1)

• POSTOPERATIVE PAIN ACCORDING TO VAS

  24 H

Study Arms (2)

EMLA CREAM

ACTIVE COMPARATOR

EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS

Drug: EMLA CREAM 5 mg

LIDOCAINE INFILTERATION

ACTIVE COMPARATOR

LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS

Drug: LIDOCAINE 1 %

Interventions

EMLA CREAM 5 mg DRUG

EMLA CREAM APPLICATION FOR WOUND AFTER CS

Also known as: EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25

EMLA CREAM

LIDOCAINE 1 % DRUG

LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS

Also known as: XYLOCAINE

LIDOCAINE INFILTERATION

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 40 years.
• Patient American Society of Anesthesiologists physical status І or П.
• Gestational age of pregnancy of 37w or more.
• Patient have no previous section or have 1or 2 previous sections.
• Patient having no medical disorders.
• Patient with no obstetrical complications.

You may not qualify if:

• age below18 or above 40.
• Women American Society of Anesthesiologists physical status ш or more.
• Women having more than 2 previous cesarean section.
• Women receive cardio vascular drugs or having history of cardio vascular disease.
• Women with Medical disorders with pregnancy as diabetes milletus.
• Women having obstetrical complications as antepartum hemorrhage, pre-eclampsia or eclampsia.
• Women having metabolic, hormonal, respiratory, renal and hepatic disease.
• Women with any severe allergic condition or severe asthma.
• Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams university Maternity hospital

Cairo, Abbasya, 11821, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• MAGED R ABO SAEDA, MD

  AIN SHAMS MATERNAL HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HANY A IBRAHIM, MBBCH

CONTACT

01220034468; DR.HANY_AYAD@YAHOO.COM

AHMED M MAMDOUH, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT DOCTOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: September 15, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

EG (1)